JP2018530356A - Enteral nutrition satiety device - Google Patents

Abstract

A device is provided for inducing satiety in a patient undergoing enteral nutrition treatment. In one aspect, an enteral feeding device is provided that includes a catheter tube and an expandable bladder secured to the distal end of the tube. The expandable bladder can be placed in the patient's body lumen to receive and administer nutrients to the patient. In another aspect, a satiety inducing device is provided for continuously administering nutrition to a patient. The satiety inducing device includes an enteral feeding tube and an expandable bladder secured to the distal end of the tube, the expandable bladder being secured near the distal end of the tube and within the patient's body lumen. Can be detained. The expandable bladder expands when it receives nutrients to occupy the volume of the body lumen and contracts when the nutrients are continuously administered to the patient.
[Selection] Figure 2A

Description

  The present invention relates to a device for enteral nutrition of a patient. More particularly, the present invention relates to a device for inducing satiety in enteral nutrition patients.

  There are various situations that require catheter intubation into the human body to achieve the desired medical purpose. A relatively common situation is the drainage of residual fluids and the supply of nutrient solutions and drugs directly to the stomach and intestines. In these situations, after forming a fistula percutaneously, an indwelling device is inserted through the fistula and placed. As an example, this surgical opening and / or the procedure of creating a fistula leading from the stomach wall or intestinal wall to the outer surface of the skin is commonly referred to as “gastric fistula”. By injecting a nutrient solution through a device having a catheter element placed through such a fistula, such as a feeding tube, nutrients can be supplied directly to the stomach and intestines (known as enteral feeding) Various devices for enteral nutrition have been developed over the years, including not only devices with conventional or non-thin structures but also “thin parts” that rest on the patient's skin. Is included. Such transdermal delivery devices (sometimes referred to as “transdermal delivery catheters”) are often “gastrostomy tubes”, “percutaneous gastrostomy catheters”, “PEG (Percutaneous Endoscopic Gastrostomy) tubes”, or “ It is called “enteral feeding tube”. An example of such a device is US Pat. No. 6,019,746 entitled “Low Profile Balloon Feeding Device” granted to Picha et al. Document 1).

  As mentioned above, there are various examples that require the use of a catheter, one of which is when the patient's stomach function has been compromised for a period of time, as is often seen after major surgery. As with other cases where stomach function is impaired or restricted, in addition to the need to supply or replenish the body with a certain level of nutrients etc. after surgery, a further problem is that no nutrition is provided The intestine can be a source of bacteria that enter the bloodstream. This type of problem can be solved by introducing nutrients through the patient's abdominal wall, stomach wall, pylorus, duodenum, through an enteral feeding device tube properly inserted into the jejunum at the tip of the Triz ligament. .

  In general, patients who have undergone enteral nutrition and have reflux or aspiration problems do not have the sensation of being full or “full”. This is because such patients are fed through the jejunum, i.e. nutrition is being fed directly into the small intestine, or food has been continuously administered to the stomach for over 12 hours, for example. It is. Thus, such patients generally do not eat on a “normal” or general diet, eg twice or three times a day, when the stomach receives a lump of food and swells It is not possible to get a sense of eating enough, which is a common sensation.

  Accordingly, enteral nutrition devices that provide improved satiety for patients are useful. More particularly, enteral feeding devices that mimic or reproduce the sensation of satiety while feeding continuously are beneficial. In addition, enteral nutrition devices that incorporate balloons for indwelling within the patient that receive a lump of food and continuously provide food to the patient are advantageous.

US Pat. No. 6,019,746

  Aspects and advantages of the invention are set forth in part in, or may be apparent from, the following disclosure. Alternatively, it can be understood through an embodiment of the present invention.

  In one aspect, the present subject matter relates to enteral feeding devices. The device includes a catheter tube having a tube distal end and a tube proximal end. The first retainer is secured to the catheter tube at the tube proximal end, and the second retainer is secured to the catheter tube at the tube distal end. The first retainer is an external retainer for placement outside the patient's body, and the second retainer is an indwelling retainer for placement within the patient's internal lumen. The device also includes an expandable bladder secured to the catheter tube at the distal end of the tube. The expandable bladder can be placed in the patient's body lumen for receiving and administering nutrients to the patient.

  In some embodiments, the bladder is a permeable membrane. In other embodiments, the device includes a flow control valve for administering nutrients from the bladder. The bladder can be formed of, for example, a material having elasticity suitable for repeated expansion and contraction, or any other material.

  In various embodiments, the internal lumen is the patient's stomach and the bladder can be placed inside the patient's stomach. The bladder can swell and accept a bolus dose of nutrients, and more specifically, the bladder can swell and occupy the volume of the patient's body lumen. In exemplary embodiments, nutrients are administered at a continuous rate, but in other embodiments, nutrients may be administered at other suitable rates or intervals.

  In still other embodiments, the first retainer is the base of a thin enteral feeding device, and in yet other embodiments the second retainer is an inflatable balloon. Other configurations of the device can be used as well.

  In another aspect, the present subject matter relates to a satiety induction device for intermittently administering nutrition to a patient. The device includes an enteral feeding tube having a tube distal end and a tube proximal end. The distal end of the tube can be placed within the patient's internal lumen. The first retainer is secured to the enteral feeding tube at the proximal end of the tube. The first retainer is an external retainer for placement outside the patient's body. The device further includes an expandable bladder secured near the distal end of the enteral feeding tube, the expandable bladder being positionable within the patient's body lumen. The expandable bladder swells to accept the nutrients and occupies the volume of the body lumen and contracts when the nutrients are continuously administered to the patient.

  In some embodiments of the satiety inducing device, the bladder is made of a permeable membrane, and in other embodiments, the device includes a flow control valve for controlling the flow rate of nutrients from the bladder. In the exemplary embodiment, the bladder is formed of a resilient material, but in other embodiments, the bladder may be made of any other material suitable for repeated expansion and contraction, for example. In yet another embodiment, the internal lumen is the patient's stomach and the bladder can be placed inside the patient's stomach.

  Additionally or alternatively, the retainer can be the base of a thin enteral feeding device. In some embodiments, the retainer is a first retainer and the device further includes a second indwelling retainer. For example, the second retainer may be an inflatable balloon, although other types or configurations of indwelling retainers may be used. Furthermore, other configurations of satiety inducing devices can be used as well.

  These and other features, aspects, and advantages of the present invention will be more clearly understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, clarify the principles of the invention.

  The complete and feasible disclosure of the present invention directed to those skilled in the art includes the best mode and is described in the specification with reference to the accompanying drawings.

FIG. 1 is a schematic cross-sectional view of an enteral feeding device or satiety inducing device according to an exemplary embodiment of the present inventive subject matter. 2A is an enteral feeding device or saturable device of FIG. 1 having an expandable bladder placed in a patient's body lumen and in a deflated or non-inflated state, according to an exemplary embodiment of the present inventive subject matter. It is the schematic of a full induction device. 2B is a schematic diagram of the enteral feeding device or satiety-inducing device of FIG. 2A having an expandable bladder in an expanded or expanded state, according to an exemplary embodiment of the present inventive subject matter. 2C is a schematic diagram of the enteral feeding device or satiety-inducing device of FIG. 2A having an expandable bladder in an inflated or expanded state, according to another exemplary embodiment of the present inventive subject matter. is there.

  Reference will now be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For example, features illustrated or described as part of one embodiment can be used in other embodiments to yield yet another embodiment. Accordingly, the present invention is directed to such modifications and changes as being within the scope of the claims and the equivalents to the claims.

  Further, no particular designation of components, capitalization of terms, attributes, data structures, or any other programming or structural aspects are required or critical, and mechanisms that implement the invention or features of the invention. Can have different names, formats, or protocols. Also. Particular functional portions between the various components disclosed herein are merely exemplary and are not required. That is, functions performed by a single component may instead be performed by multiple components, and functions performed by multiple components may instead be performed by a single component. Good.

  The present invention relates to a non-vascular catheter device having a catheter tube, such as an enteral feeding device, an external retainer (eg, a base disposed outside the human body), and a patient's body lumen or body cavity. (E.g., a non-vascular lumen of the body, such as a gastric lumen, jejunum, or peritoneal cavity). For example, an indwelling retainer is a retention mechanism for a catheter device that prevents the catheter device from being withdrawn from the patient, and the indwelling retainer can be inserted into the body lumen through the stomach. Insertion through the stomach may be from outside the body or may be performed from inside the body using endoscopic techniques. In this context, the term “insertion” is to be understood as inserting or introducing a catheter tube into a fixed place in the stomach, where the base is placed outside the human body and the indwelling retainer Is placed in a non-vascular lumen or body cavity. Generally, the catheter device is an enteral feeding device such as a configurable PEG (Percutaneous Endoscopic Gastrostomy) device or a “C-PEG (Configurable-PEG)” device.

  Referring to FIG. 1, a side schematic view of a non-vascular catheter device is provided in accordance with an exemplary embodiment of the present inventive subject matter. More particularly, the non-vascular catheter device of the exemplary embodiment of FIG. 1 is an enteral feeding device 100 (which may also be referred to as a “PEG” device), for the enteral feeding device 100 to pass the catheter. A flexible catheter 102 (which may also be referred to as a “tube”, “nutrition tube”, or “shaft”) having a wall defining at least one nutrient lumen 104. Enteral feeding device 100 is located within a base 106 (FIGS. 2A-2C) disposed outside of patient P's body and within non-vascular body lumen of patient P (eg, a gastric lumen such as the patient's stomach). And an indwelling retainer for indwelling. The base 106 may also be the first or external retainer of the enteral feeding device 100 and the indwelling retainer may be the second or internal retainer of the enteral feeding device 100.

  In general, the base 106 of the enteral feeding device 100 has one or more openings or ports 110 that allow access to the feeding lumen (s) 104 of the catheter 102, for example. As shown in FIG. 1, the flexible catheter 102 has a tube proximal end 112, a tube distal end 114, a longitudinal axis A, a transverse axis W, and a length L. Further, in the embodiment shown in FIG. 1, the catheter 102 is placed through a base 106 that communicates with one or more ports 110 in the base. The wall of the catheter 102 defines one or more nutrient lumens 104 that extend from the port (s) 110 in the base 106 to the tube distal end 114 of the catheter 102. The nutritional lumen (s) 104 may be in communication with one or more openings in the second retainer 108.

  The second retainer 108 may be a conventional molded flexible retainer, or an “inserted” state or “where the retainer diameter is generally about the same as the catheter portion of the enteral feeding device. A configurable retainer in which the retainer takes an expanded shape from an "extracted" state and changes to an expanded "holding" or "in-dwelling" state where the retainer diameter is substantially larger than the catheter portion of the enteral feeding device There may be. Such a configurable PEG device may be referred to as a C-PEG device. In various embodiments, the configurable second retainer 108 may be an inflatable or non-inflatable retainer, with the expanded shape being a mushroom, dome, sphere, hemisphere, donut, or other suitable shape It may be.

  The second retainer 108 is secured away from the tube proximal end 112 of the catheter 102 of the enteral feeding device 100. More specifically, the second retainer 108 is secured to the catheter 102 near the tube distal end 114 of the catheter 102. As described above, the second retainer 108 is an indwelling retainer configured to be placed in a non-vascular body lumen such as a patient's stomach. In the exemplary embodiment, the second retainer 108 is an inflatable balloon that receives liquid through the inflation lumen 116 and can extend through the base 106. In other embodiments, the second retainer 108 may be a non-inflatable retainer and the inflation lumen 116 is not required.

  As previously described, a base 106, which may be a first external retainer configured to be placed outside the patient's body, may be secured to the catheter 102. As shown in FIG. 1, a base 106, which may be a first retainer, is secured to the catheter 102 proximate to the second retainer 108, and more specifically, at or near the tube proximal end 112 of the catheter 102. It is fixed in the vicinity. In the exemplary embodiment of FIG. 1, the first retainer or base 106 is the base of a thin PEG device and has a proximal proximal surface 118 and a proximal distal surface 120. When the enteral feeding device 100 is deployed for implementation, i.e., to supply nutrients to the body lumen of the patient P, the proximal distal surface 120 is pressed against or against the patient's skin. Adjacent to each other. As described above, the base 106 may define one or more ports 110. For example, the base 106 may define one port 110 that provides access to the catheter 102 and a second port 110 that provides access to the inflation lumen 116 for inflating the balloon that is the second retainer 108. . A plug 122 may be included in each port 110, for example, the port may be closed when not in use. One or more plugs 122 may be attached to base 106 by tether 124. Of course, in other embodiments, each plug 122 may be remote from the base 106 or may not be attached to the base 106. In addition or alternatively, one or more ports 110 can incorporate a check valve to allow inflow of fluid, eg, nutrients, for delivery to patient P, but fluid flows out through port 110. To prevent.

  Referring also to FIG. 1, in some embodiments, a connector 126 is used to connect the catheter 102 or feeding tube to a source of nutrient solution such as a syringe or other suitable injector provided to the patient P. You may let them. The connector 126 may be disposed on the base 106 such that the connector 126 and the source of nutrients are in fluid communication with the nutrition lumen 104 of the catheter 102 and the nutrients may be delivered to the patient P. It will be appreciated that the connector 126 may have any suitable shape for connecting a nutrient source with the enteral feeding device 100, or in suitable embodiments, the connector 126 may be omitted.

  As further shown in FIG. 1, enteral feeding device 100 includes an expandable bladder 130 secured to catheter 102 at or near the distal tube end 114 of the catheter. As described in more detail below, the bladder 130 receives and expands nutrients, or a lump of food, thereby occupying the volume of a body lumen such as the patient's stomach and inducing a feeling of satiety for the patient. The bladder 130 is configured to administer food or nutrients at a continuous rate and maintain the clinical utility of continuous feeding. Thus, enteral nutrition device 100 including bladder 130 can also be disclosed as a satiety inducing device for continuously administering nutrition to a patient.

  Like the second retainer 108, the bladder 130 is an arrangement component of the enteral feeding device 100. That is, the bladder 130 can be placed in the internal lumen of the patient P, such as the patient's stomach S, as shown in FIGS. With particular reference to FIG. 2A, a schematic view of enteral feeding device 100 in the proper position for use with patient P is shown. As shown in the exemplary embodiment, the catheter 102 or feeding tube is placed through a fistula formed from the stomach wall to the patient's skin, and the catheter 102 extends from the stomach S to the outside of the patient P. The base distal surface 120 of the base 106 is placed in contact with the patient's skin and the second retainer 108 placed therein is placed inside the patient's stomach S to enter the enteral feeding device for enteral feeding. Hold in the desired position.

  As further shown in FIG. 2A, bladder 130 is generally in a deflated or non-inflated state. However, when the bladder 130 receives nutrition and administers it to the patient P, the bladder 130 expands as shown in FIGS. 2B and 2C. With particular reference to the schematic diagram of FIG. 2B, the bladder 130 receives and expands a dose of nutrient or food mass to occupy the volume of the stomach S of the patient. Thus, when receiving nutrients, the bladder 130 is in an expanded or expanded state. In the exemplary embodiment of FIG. 2B, the expandable bladder 130 is a permeable membrane 132 that allows nutrient N to gradually penetrate the patient's stomach S through the membrane. it can. More specifically, the permeable membrane allows nutrient N to pass from the interior 134 of the bladder 130 beyond the outer surface 136 of the bladder 130. In various embodiments, the permeable membrane may be made from GORE-TEX® or other suitable permeable material. The material forming the permeable membrane is such that the nutrient N penetrates the material at a substantially constant or continuous rate, for example to approximate the continuous nutritional administration of known enteral nutrition assemblies. Can be selected.

  Referring now to the schematic diagram of FIG. 2C, in another exemplary embodiment, bladder 130 includes a flow control valve 138 to control the flow rate at which nutrients are administered from bladder 130 to patient P. In some embodiments, the flow control valve 138 may be a pressure compensated flow control valve mounted on or incorporated in the bladder 130. Other suitable valves can be used as well, and in some embodiments, bladder 130 can include one or more flow control valves 138.

  It will be appreciated that in some embodiments, the bladder 130 is a permeable membrane and may include a flow control valve 138. Further, regardless of whether the bladder 130 is a permeable membrane 132 and / or includes a flow control valve 138, the bladder 130 can be made of an elastic material, or other suitable material. The bladder 130 can be repeatedly expanded and contracted to receive the nutrient N and administer it to the patient P. Further, the bladder 130 and enteral feeding device 100, or satiety-inducing device may also have other suitable configurations.

  When the bladder 130 is expanded as shown in FIGS. 2B and 2C, the patient's stomach expands or expands to receive the nutrient mass. Swelling or dilatation of the patient's stomach induces a feeling of “fullness” or satiety. However, because the bladder 130 is made of a permeable material or incorporates a flow control valve or other suitable feature for the gradual administration of nutrients, continuous or administration of jejunal nutrition Clinical utility, such as reduced reflux or aspiration, can be similarly achieved by the enteral feeding device 100. Thus, patient P receives a more conventional feeding therapy, eg, bolus administration of nutrients twice or three times a day, mimicking two or three meals, in a continuous manner. Receive and "feed" nutrition.

  Various patents are incorporated herein by reference, and so long as there is a conflict between the incorporated material and the material of the written specification, the written specification shall control. Furthermore, the written specification uses examples to disclose the invention, including the best mode, and to create and use any device or system and implement any integrated method. It also allows any person skilled in the art, including The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other embodiments are within the scope of the claims if they contain structural elements that do not differ from the language of the claims, or if they contain equivalent structural elements that do not differ significantly from the language of the claims. Is intended.

Claims (18)

Enteral nutrition device,
A catheter tube having a distal end of the tube and a proximal end of the tube;
A first retainer that is secured to the catheter tube at the proximal end of the tube and is an external retainer for placement outside the patient's body;
A second retainer that is secured to the catheter tube at the distal end of the tube and is an indwelling retainer for placement within a patient's body lumen;
An expandable bladder secured to the catheter tube at the distal end of the tube and capable of being placed in the body lumen of the patient for receiving and administering nutrients to the patient. Intestinal nutrition device. The device of claim 1, comprising:
A device wherein the bladder is a permeable membrane. The device of claim 1, comprising:
The device further comprising a flow control valve for dispensing nutrients from the bladder. The device according to any one of claims 1 to 3,
A device wherein the bladder is made of an elastic material. The device according to any one of claims 1 to 4,
A device wherein the internal lumen is the stomach of the patient. The device according to any one of claims 1 to 5,
A device wherein the bladder is expanded to receive a single bolus of nutrition. The device according to any one of claims 1 to 6,
A device wherein the bladder expands and occupies the volume of the body lumen. The device according to any one of claims 1 to 7,
A device wherein the nutrient is administered at a continuous rate. The device according to any one of claims 1 to 8,
The device, wherein the first retainer is a base of a thin enteral feeding device. The device according to any one of claims 1 to 9,
The device, wherein the second retainer is an inflatable balloon. A satiety inducing device for continuously administering nutrition to a patient,
An enteral feeding tube having a distal end of the tube that can be placed in the lumen of the patient and a proximal end of the tube;
A first retainer that is secured to the enteral feeding tube at the proximal end of the tube and is an external retainer for placement outside the patient's body;
An expandable bladder that is secured to the enteral feeding tube near the distal end of the tube, can be placed in the patient's body lumen, and is expanded when receiving nutrients; A satiety-inducing device comprising the expandable bladder that occupies a volume and contracts when nutrients are continuously administered to the patient. The device of claim 11, comprising:
A device wherein the bladder is a permeable membrane. The device of claim 11, comprising:
A device further comprising a flow control valve for controlling the flow rate of nutrients from the bladder. The device according to any one of claims 11 to 13,
A device wherein the bladder is made of an elastic material. The device according to any one of claims 11 to 14,
A device wherein the internal lumen is the stomach of the patient. The device according to any one of claims 11 to 15,
A device wherein the external retainer is the base of a thin enteral feeding device. The device according to any one of claims 11 to 16, comprising:
The device further comprising a second retainer in which the outer retainer is a first retainer and the device is an indwelling retainer. The device of claim 17, wherein
The device, wherein the second retainer is an inflatable balloon.

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